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人工耳蜗植入治疗单侧耳聋和不对称听力损失的成本效益:一项随机对照试验的结果。

Cost-utility of cochlear implantation in single-sided deafness and asymmetric hearing loss: results of a randomized controlled trial.

作者信息

Marx Mathieu, Mounié Michaël, Mosnier Isabelle, Venail Frédéric, Mondain Michel, Uziel Alain, Bakhos David, Lescanne Emmanuel, N'Guyen Yann, Bernardeschi Daniele, Sterkers Olivier, Godey Benoit, Creff Gwenaëlle, Schmerber Sébastien, Bonne Nicolas-Xavier, Vincent Christophe, Fraysse Bernard, Deguine Olivier, Costa Nadège

机构信息

Service d'Otologie, Otoneurologie et ORL Pédiatrique, Hôpital Pierre-Paul Riquet, CHU Toulouse Purpan, Place du Dr Baylac, Toulouse Cedex, 31059, France.

Brain & Cognition Research Centre, UMR 5549, Université Toulouse III, Toulouse, France.

出版信息

Eur J Health Econ. 2024 Nov 20. doi: 10.1007/s10198-024-01740-9.

Abstract

OBJECTIVES

To determine the Incremental Cost-Utility Ratio (ICUR) of cochlear implantation in the treatment of adult patients with single-sided deafness (SSD) and asymmetric hearing loss (AHL).

METHODS

This prospective multicenter pragmatic study including a randomized controlled trial (RCT) enrolled 155 subjects with SSD or AHL. Subjects chose a treatment option between: abstention, Contralateral Routing Of the Signal hearing aids, Bone Conduction Device or Cochlear Implant (CI). Participants who opted for CI were then randomized between two arms: "immediate CI" where the cochlear implantation was performed within one month and "initial observation" where subjects were first observed. The ICUR of CI was determined at 6 months follow-up by comparing the two arms. Utility was measured using EuroQoL- 5 dimensions (EQ-5D), to calculate the gain in Quality-Adjusted Life Years (QALY). Individual costs were extracted from the French National Health Insurance database. A Markovian MultiState (MMS) model assessed the ICUR evolution over the lifetime horizon.

RESULTS

Among the 155 included participants, 51 opted for a CI and were randomized. For a 6 months follow-up period, the ICUR was €422,279/QALY gained after CI. Using the MMS model, the ICUR of CI decreased to €57,561/QALY at 10 years follow-up, €38,006/QALY at 20 years, and dropped to €26,715 at 50 years. In the participants with severe tinnitus, mean ICUR was €31,105/QALY at 10 years.

CONCLUSIONS

CI can be considered as an efficient treatment in SSD and AHL from 20 years follow-up in the global population, and before 10 years follow-up in patients with severe associated tinnitus.

摘要

目的

确定人工耳蜗植入治疗成人单侧耳聋(SSD)和不对称听力损失(AHL)的增量成本-效用比(ICUR)。

方法

这项前瞻性多中心实用研究包括一项随机对照试验(RCT),纳入了155例SSD或AHL患者。受试者在以下治疗方案中进行选择:不治疗、对侧信号路由助听器、骨传导装置或人工耳蜗植入(CI)。选择CI的参与者随后被随机分为两组:“立即CI”组,即在1个月内进行人工耳蜗植入;“初始观察”组,即先对受试者进行观察。通过比较两组在6个月随访时确定CI的ICUR。使用欧洲五维健康量表(EQ-5D)测量效用,以计算质量调整生命年(QALY)的增益。个体成本从法国国家健康保险数据库中提取。马尔可夫多状态(MMS)模型评估了ICUR在整个生命周期内的演变。

结果

在155名纳入的参与者中,51人选择了CI并被随机分组。在6个月的随访期内,CI后的ICUR为每获得1个QALY 422,279欧元。使用MMS模型,CI的ICUR在10年随访时降至每QALY 57,561欧元,20年时降至每QALY 38,006欧元,50年时降至26,715欧元。在伴有严重耳鸣的参与者中,10年时的平均ICUR为每QALY 31,105欧元。

结论

在全球人群中,从20年随访来看,CI可被视为SSD和AHL的有效治疗方法;在伴有严重耳鸣的患者中,在10年随访之前即可考虑。

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